Compact suture punch with malleable needle

ABSTRACT

A suture punch system that is capable of directly passing braided suture through tissue in a simple, one-step process. The system includes three principle components: a malleable needle capable of delivering the suture to the tissue, a handheld instrument for grasping tissue and controlling needle placement, and a force-supplying mechanism to supply the force required for needle placement. Needle deformation begins at the tip of the instrument, which beneficially includes a curved segment. As the distal tip of the needle pierces the tissue, it continues its radial path through the tissue. When the proximal end of the needle exits from the instrument, the needle may be radial in shape and traverses an essentially radial path through the tissue. Once the needle has passed entirely through the tissue, it may be retrieved using the jaws of the punch or another instrument.

REFERENCE TO RELATED APPLICATION

This application is a continuation application of U.S. patentapplication Ser. No. 10/815,338, filed Apr. 1, 2004, which acontinuation-in-part application of U.S. patent application Ser. No.10/165,468, filed Jun. 7, 2002, which claims priority to U.S.Provisional Patent Application Ser. No. 60/310,220, filed Aug. 6, 2001.

FIELD OF THE INVENTION

This invention relates generally to surgical suturing and, inparticular, to improved articles, instrumentation, and methodstherefore.

BACKGROUND OF THE INVENTION

Suture passing is problematic for the arthroscopic surgeon because thebraided suture preferred by most arthroscopists cannot be pushed througha cannulated instrument. Braided suture must be pulled into locationbecause applying a push force causes the braid to expand in diameter,thereby wedging in the instrument.

Various solutions have been devised for passing braided suture. TheCaspari Suture Punch (Linvatec Corporation, Largo, Fla.) has been a veryuseful arthroscopic suture-passing instrument. Tissues may be approachedhead on, grasped and punctured with a cannulated needle, thenmonofilament suture wheeled through the tissue. A doubled monofilamentmay be used as a shuttle to pass another braided suture or,alternatively, a Linvatec Suture Shuttle may be wheeled through aslotted Caspari Suture Punch and used to shuttle suture. SurgicalDynamics has a similar device that shuttles a needle from one side ofthe punch to the other, passing the needle and attached thread throughtissue.

The Caspari suturing instrument, described in U.S. Pat. Nos. 4,890,615,4,923,461 and 4,957,498, includes a hollow needle for penetrating tissueto be sutured within the body while the tissue is clamped betweenrelatively movable jaws, and a suture feed mechanism for feeding suturematerial through the hollow needle such that the jaws may be opened andthe suturing instrument withdrawn from the body pulling the free endsegment of the suture material with the instrument. A knot may be tiedin the suture material externally of the body and the knot moved backinto the body at a position adjacent the tissue.

U.S. Pat. No. 5,254,126 discloses an endoscopic suture punch for use inendosurgical procedures having an elongate frame and a handle mounted toone end of the frame. A pair of opposed jaws having tissue punches ismounted to the other end of the frame. One jaw is rigidly mounted to theframe while the other jaw is movably mounted to the frame, although bothjaws may be movably mounted. An actuation handle is mounted to the framefor actuating the jaws. The suture punch has a suture pathway throughthe frame, the punches and the jaws for receiving the suture. There is asuture drive mechanism mounted to the frame for moving the suturethrough the suture pathway.

The surgical suturing apparatus described in U.S. Pat. No. 5,454,823comprises upper and lower jaw elements selectively movable relative toone another between open and closed position. Each jaw element isprovided with a respective recess arranged to receive a portion of anelongate incision member or length of surgical thread and securing meansis provided arranged to selectively secure the surgical incision memberor length of surgical thread in a respective recess. The jaw elementsare typically provided at an end of an elongate positioning andoperating arm making the device particularly useful for use inlaparoscopic surgery.

More recently, U.S. Pat. No. 6,051,006 describes a suture-passingforceps having a first jaw with a mount which supports a needled sutureand a second jaw having a passage, which when aligned with the mount, ispositioned to receive the needled suture. The second jaw is positionedrelative to the mount in a manner which allows delivery of theinstrument to a surgical site in a low profile, delivery position (e.g.,with the jaws spaced relatively closely). The surgical instrumentincludes an elongated shaft having a distal region for supporting thejaws. The second jaw is pivotable, with respect to the mount, betweenthe delivery position in which the second jaw is spaced relativelyclosely to the mount with the passage misaligned with the mount and anopen, misaligned position, the second jaw being axially translatablerelative to the mount to an open, aligned position in which the passageis aligned with the mount.

A shortcoming of these and other such devices is the lack of roomavailable to open the jaws sufficiently in tight spaces (a clearanceissue), difficulty in forcing the tooth through the full thickness ofthe tissue (the tip gradually dulls and some tissue like the rotatorcuff is just too thick) and fairly large diameter cannulas are requiredfor passage.

Other “blitzes” and similar devices also have rather large diametercannulated needles that pierce the tissue then deploy a loop or othermechanism to transport suture through the tissue. These are cumbersometo use, often requiring skillful rotation and pushing of the device bythe surgeon to accomplish the selected result. Additionally, someconcern exists with regard to the size of the hole placed in the tissueand the amount of damage requiring repair. This is especially true ofthe newer “Arthropierce” instrument currently in use.

Common to existing devices is a body capable undergoing elasticdeformation during use but which retains a preformed shape when in anunconstrained condition. Of particular usefulness in these devices isNitinol, a so-called “shape retention” alloy having an extremely highyield point. Nitinol components are formed during manufacture to aselected shape, and will return to this shape when in an unconstrainedcondition even after undergoing significant deformation. PreformedNitinol needles and shuttles may be passed through cannulatedinstruments and will return to their original shapes when in anunconstrained state. This allows shuttle loops to be passed throughcannulated instruments without permanent deformation. All Nitinolcomponents may be formed to their selected shapes during manufacture.

As an example of an invention utilizing this effect, U.S. Pat. No.5,607,435 describes a medical instrument including a tubular sectionhaving a leading end terminating in a sharp point and a surgical needleexhibiting “superelastic characteristics.” As such, the needle mayremain straight as it is inserted through the delivery tube withoutdeveloping substantial permanent deformation. While in the delivery tubeand in this substantially straight condition, the needle is delivered tothe suturing site. Once at the suture site, the surgical needle isextended out of the leading end of the delivery tube, returning it toits original curved or bent shape for suturing. A suture thread or wireis operatively disposed in the bore of the tubular section with one endextending out the tip through a slot so as to remain in position to forma suture upon removal of the tubular needle from tissue. A tweezersinstrument may then be used to grip and tie the thread into a sutureknot.

Similarly, U.S. Pat. No. 5,749,879 discloses a cannulated instrument foruse in conjunction with “an elastic needle.” In the preferredembodiment, the needle is of a pseudoelastic shape memory alloy and hasan arced shape while the needle's alloy is in a substantially austeniticphase, and the needle may be stressed into a more straight shape inwhich the needle's alloy enters an at least partially more martensiticphase. When the needle is held entirely within the cannula, the needleis straightened and contains more stress-induced-martensite phase. Asthe needle is extruded from the distal end portion of the cannula, thatportion of the needle which extends beyond the cannula returns towardits original shape by a martensitic-to-austenitic shape memory phasechange caused by at least partial relief of thestress-induced-martensite in the needle's alloy. A cannula insertincludes a longitudinal bore which may be used to contain a sutureattached to the needle. Suitably, the bore may extend longitudinallyentirely through the cannula insert, to permit an unlimited length ofsuture to be pulled therethrough.

Despite these advances, the need remains for a suture punch capable ofpassing braided suture without the use of a shuttle or similar means.Beneficially, such an instrument would be capable of passing suturewhile not requiring multiple or complex sequential operations or a highlevel of surgeon skill. In other embodiments, it would also bebeneficial that the suture punch pass through a small diameter (i.e., 8mm or less) cannula, and that the hole created in the tissue for passageof the suture be as small as possible.

SUMMARY OF THE INVENTION

This invention overcomes deficiencies in the prior art by providing asuture punch system capable of directly passing suture material, such asbraided suture material, through tissue in a simple, one-step process.The system includes three principle components: a malleable needlecapable of delivering the suture material to the tissue, a handheldinstrument for grasping tissue and controlling needle placement, and atrocar or other mechanism to supply the force required for needleformation and placement.

The needle differs from standard needles in terms of size, shape andmaterial properties. In beneficial embodiments, the needle is shorterthan standard needles, generally 10 to 13 mm in length, and has across-section which may be circular or non-circular, includingrectangular with at least two parallel sides. The rectangular needlesmay have varying thicknesses and have a cross-section that ranges fromsubstantially square to substantially flat. Additionally, the needle ismade of a malleable material permitting it to be shaped within thehandheld instrument and to retain its form while passing through tissue.The needle may also return to its form after passing through the tissueor once any bending force has been removed. Similarly, the distalportion of the trocar may be malleable, thereby permitting shapingwithin the handheld instrument.

In contrast to existing suture punches in which the needle or shuttleundergoes only an elastic deformation during use and the functionalun-constrained shape of the needle or shuttle is produced duringmanufacture, the needle of the disclosed device may be inelasticallyformed to its functional shape during use, allowing the needle totraverse a nonlinear path. More particularly, when passing through thedistal tip of the hand instrument, the needle may be inelasticallyformed by a radial path within the instrument, the plane of the radiusbeing substantially unparallel to the tissue through which the suture isbeing passed. The formation of this radius is facilitated by theaforementioned parallel sides of the needle cross-section which areconstrained by the instrument in such a manner as to place themessentially in the plane of the tissue.

Needle deformation begins as the tip of the needle passes through theradius within the instrument and continues as the needle is forceddistally by a force-supplying mechanism. As the distal tip of the needlepierces the tissue, it continues its radial path through the tissue, theradius of the path being determined by the unconstrained radius of theneedle. This unconstrained radius may be larger than that of the formingradius within the instrument due to “spring back” of the needle, thedegree of which is determined by the material properties of the needle,its cross section, and features formed in the parallel surfaces of theneedle during manufacture.

Forming of the needle along its length continues as it is passes fromthe distal tip of the instrument into the tissue. When the proximal endof the needle exits from the instrument, the needle may be entirelyradial in shape and traverse an essentially radial path through thetissue. Due to the degree of spring back, the needle, in certainembodiments, may also return to its non-deformed shape. As used herein,the term “spring back” is meant to define the degree of elasticity ofthe malleable needle after it has exited the instrument. A “spring back”of 100 percent would apply to a needle that returns to its originalshape whereas a needle having a “spring back” of 0 percent wouldmaintain the shape of the curved segment of the instrument after theneedle has exited the instrument. The present invention may use needleshaving a degree of spring back of from 0 to 100 percent. In selectembodiments, wherein an inelastic material is used, the needle has aspring back of from 0 to about 10 percent. In alternative embodiments,wherein an elastic material is used, the needle has a spring back offrom about 90 to about 100 percent.

After the proximal end of the needle exits the instrument, the needlemay be propelled further along its radial path by the force-supplyingmechanism, such as a trocar. Additionally, the distal portion of themechanism may be formed to a radial shape by the instrument in the samemanner as the needle. Additionally, the radial shapes of the needle andmechanism may also be coplanar. Engagement of the mechanism with theneedle after the needle passes from the instrument may be facilitated bymating surfaces of the mechanism and needle, shaped, for example, toprevent radial or lateral displacement of the needle proximal andmechanism distal surfaces. The mechanism may also be engaged with theneedle in a manner that connects the mechanism and needle together suchthat the connection is capable of being broken after the needle hasexited the instrument.

The passage in the instrument within which the needle travels, and theforming radius in the instrument distal tip, each comprise open-sidedchannels allowing the suture carried by the needle to travel unimpededduring its forming and insertion into the tissue. As the force-supplyingmechanism pushes the needle further into the tissue, the suture iscarried along by the needle through the passage formed in the tissue todeliver the suture to the tissue.

During use, the tissue to be sutured is constrained by pressure appliedthrough closure between the upper, moveable jaw of the instrument andthe distal portion of the instrument which acts as a fixed jaw. Theupper, movable jaw contains a shaped passageway that allows the curvedneedle to pass therethrough during use. After the force-supplyingmechanism has been fully inserted into the instrument and the needle hasachieved maximum travel into the tissue, the mechanism may be withdrawnfrom the instrument.

When suturing thin sections, the needle may be passed completely throughthe tissue and may then be ready for retrieval using the jaws of thepunch or another instrument. In the case of thick tissue, 70 percent ormore of the needle may protrude from the tissue after theforce-supplying mechanism is fully inserted, such that opening the upperjaw slightly and moving the instrument in a proximal direction wouldcause the needle to wedge in the upper jaw passage, permitting theneedle to be withdrawn completely from the tissue. Following thisprocedure, the needle may be retrieved using the punch or anotherinstrument.

Accordingly, in one embodiment, the present invention provides suturinginstrumentation for suturing tissue having a malleable needle portionhaving a sharpened distal tip and constructed and arranged to deliver alength of suture material to the tissue; a handheld instrument having apassageway and having a distal end terminating in a nonlinear portionhaving a first radius; and a force-supplying structure for applying aforce to the needle portion, wherein the force-supplying structureincludes a distal end capable of pushing the malleable needle portionthrough the nonlinear portion, such that when the distal end of thehandheld instrument is positioned proximate to the tissue to be suturedand the malleable needle portion is pushed by the distal end of theforce-supplying structure through the nonlinear portion, the needleportion is deformed, thereby causing the needle portion to deliver thesuture material to the tissue.

In another embodiment, the present invention provides suturinginstrumentation for suturing tissue having a malleable needle portionhaving a sharpened distal tip and constructed and arranged to deliver alength of suture material to the tissue; a handheld instrument having apassageway and having a distal end terminating in a nonlinear portionhaving a first radius; and a force-supplying structure for applying aforce to the needle portion, wherein the force-supplying structureincludes a distal end capable of pushing the malleable needle portionthrough the nonlinear portion, such that when the distal end of thehandheld instrument is positioned proximate to the tissue to be suturedand the malleable needle portion is pushed by the distal end of theforce-supplying structure through the nonlinear portion, the needleportion is deformed, thereby causing the needle portion to deliver thesuture material to the tissue; and a jaw pivotally coupled to the distalend of the handheld instrument for holding tissue as the needle portionand suture material enters into the tissue.

In yet another embodiment, the present invention provides a sutureneedle adapted for use with a handheld instrument defining an axis andhaving an off-axis distal end, the needle including a length of materialhaving a sharpened distal tip and constructed and arranged to deliver alength of suture material; and the material of the needle beingmalleable, such that when the needle is pushed through the handheldinstrument, it elastically deforms in accordance with the off-axisdistal end.

In still another embodiment, the present invention provides a suturingsystem having a malleable needle portion having a sharpened distal tipand constructed and arranged to deliver a length of suture material; ahandheld instrument having a passageway and having a distal endterminating in a nonlinear portion; and a push member configured formovement in the passageway of the handheld instrument, the push memberbeing operative to push the malleable needle portion through thenonlinear portion, such that when the distal end of the handheldinstrument is positioned proximate to a tissue to be sutured and theneedle portion is pushed by the push member through the nonlinearportion, the needle portion is deformed and enters into the tissue anddelivers the suture material to the tissue being sutured.

In yet another embodiment, the present invention provides a method forsuturing, including the steps of providing a malleable needle portionhaving a sharpened distal tip; positioning the needle in a passageway ofa handheld instrument; providing a suture material to be delivered bythe needle portion; and using a push member to push the needle portionin the handheld instrument, the needle portion upon exiting the handheldinstrument penetrating the tissue being sutured and delivering thesuture material to the tissue being sutured.

In still another embodiment, the present invention provides a system andmethod for suturing using a smaller suture wherein the needle isdesigned such that the suture may be looped back directly into theneedle. As such, when the push member pushes the needle portion intoand/or through the tissue, the needle delivers a loop of suture materialthat may then be used as an eyelet or other mechanism for the transferof other suture. Alternatively, a smaller needle may be used duringdelivery of the suture to create a loop of suture material in the tissueto be sutured.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of a suture punch formed in accordance with theprinciples of this invention;

FIG. 2 is a side view of the instrument of FIG. 1;

FIG. 3 is an end view of the instrument of FIG. 1;

FIG. 4 is an expanded view of the distal tip of the instrument of FIG.1;

FIG. 5 is a sectional view of the distal tip of FIG. 2 at location A-A;

FIG. 6 is a sectional view of the distal tip of FIG. 2 at location B-B;

FIG. 7 is a sectional view of the instrument at location C-C;

FIG. 8 is a sectional view of the instrument at location D-D;

FIG. 9 is a sectional view of the instrument at location E-E with thetrocar and needle removed;

FIG. 10 is an expanded view of the distal tip of the instrument;

FIG. 11 is a plan view of a needle constructed in accordance with theprinciples of this invention;

FIG. 12 is a side view of the needle of FIG. 5;

FIG. 13 is an end view of the needle of FIG. 5;

FIG. 14 is a plan view of the upper jaw of the instrument;

FIG. 15 is a side view of the upper jaw of FIG. 14;

FIG. 16 is a sectional view of the upper jaw of FIG. 14;

FIG. 17 is an end view of the upper jaw of FIG. 14;

FIG. 18 is a trocar used in accordance with one embodiment of thisinvention;

FIG. 19 is an expanded view of the distal end of the trocar of FIG. 18;

FIG. 20 is an expanded sectional view of the proximal end of the trocarof FIG. 18;

FIG. 21 is an expanded view of the distal portion of the trocar of FIG.19;

FIG. 22 is an end view of the trocar of FIG. 18;

FIG. 23 is a sectional view of the instrument of FIG. 1 with trocar andneedle in place;

FIG. 24 is an expanded view of the distal portion of FIG. 23;

FIG. 25 shows a needle and trocar loaded and the upper jaw open inpreparation for use;

FIG. 26 is an expanded view of the distal end of the instrument of FIG.25;

FIG. 27 depicts the instrument grasping tissue in preparation forpassing a needle with suture therethrough;

FIG. 28 is an expanded view of the distal end of the instrument graspingtissue as shown in FIG. 27;

FIG. 29 shows the trocar now advanced so that the needle tip isbeginning to pierce tissue grasped between the instrument jaws;

FIG. 30 is an expanded view of the distal end of the instrument shown inFIG. 29;

FIG. 31 shows the trocar advanced so that the needle has approximately90 percent penetration of tissue grasped between the instrument jaws;

FIG. 32 is an expanded view of the distal end of the instrument shown inFIG. 31;

FIG. 33 shows the trocar advanced so that the needle has passed throughtissue grasped between the instrument jaws and protrudes beyond thesuperior surface of the moveable jaw;

FIG. 34 is an expanded view of the distal end of the instrument of FIG.33;

FIG. 35 shows the trocar fully advanced so that the trocar distal tiphas forced the needle proximal end significantly through the tissuegrasped between the instrument jaws;

FIG. 36 is an expanded view of the distal end of the instrument of FIG.35;

FIG. 37 is similar to FIG. 35, but with the trocar retracted so thatonly the needle and suture remain within the tissue;

FIG. 38 is an expanded view of the distal end of the device of FIG. 37;

FIG. 39 is similar to FIG. 37, but with the moveable jaw retracted;

FIG. 40 is an expanded view of the distal end of FIG. 39;

FIG. 41 is similar to FIG. 30, but with the distal end retractedproximally from the tissue so that the needle is pulled from the tissueby the moveable jaw;

FIG. 42 is an expanded view of the distal end of FIG. 41;

FIG. 43 is similar to FIG. 41, but with the needle grasped between thejaws of the instrument;

FIG. 44 is an expanded view of the distal end of FIG. 43;

FIG. 45 is similar to FIG. 43, but with the needle rotated and graspedbetween the jaws in preparation for withdrawal through the cannula;

FIG. 46 is an expanded view of the distal end of FIG. 45;

FIG. 47 is a plan view of an alternate needle configuration according tothe invention;

FIG. 47 a is a plan view of an alternate suture configuration accordingto one embodiment of the invention;

FIG. 48 is a side view of the needle configuration of FIG. 47;

FIG. 49 is an end view of the needle configuration of FIG. 47;

FIG. 50 is a plan view of yet a further alternate needle configurationaccording to the invention;

FIG. 51 is a side view of the alternate needle configuration of FIG. 50;

FIG. 52 is an end view of the alternate needle configuration of FIG. 50;

FIG. 53 is a plan view of an alternate top jaw configuration accordingto the invention;

FIG. 54 is a side view of the alternate top jaw configuration of FIG.53;

FIG. 55 is an end view of the alternate top jaw configuration of FIG.53;

FIG. 56 is a sectional view of the alternate top jaw configuration ofFIG. 53;

FIG. 57 is a sectional view of upper and lower jaws with jaws closed andneedle fully extended;

FIG. 58 is a sectional view of upper and lower jaws with jaws opened 50percent and needle fully extended;

FIG. 59 is a sectional view of upper and lower jaws with jaws opened 100percent and needle fully extended;

FIG. 60 is a sectional view of upper and lower jaws with jaws opened 100percent and the suture being pulled through the tissue;

FIG. 61 is a plan view of yet a different alternate needle according tothe invention;

FIG. 62 is a lateral side view of the different alternate needle of FIG.61;

FIG. 63 is an end-on view of the alternate needle of FIG. 61 viewed fromthe distal tip;

FIG. 64 is a plan view of an alternate construction of theupper/moveable jaw;

FIG. 65 is a side view of the alternate construction of theupper/moveable jaw of FIG. 64;

FIG. 66 is a bottom-side plan view of the alternate construction of theupper/moveable jaw of FIG. 64;

FIG. 67 is an end view of the alternate construction of theupper/moveable jaw of FIG. 64 from the proximal end;

FIG. 68 is an end view of the alternate construction of theupper/moveable jaw of FIG. 64 from the distal tip;

FIG. 69 is a sectional view of the alternate construction of theupper/moveable jaw of FIG. 64 in direction J-J;

FIG. 70 Is a sectional view of the alternate construction of theupper/moveable jaw of FIG. 64 in direction K-K;

FIG. 71 is a sectional view of the alternate construction of theupper/moveable jaw of FIG. 64 in direction L-L;

FIG. 72 is a sectional view of the upper jaw of FIG. 64 assembled to thelower jaw and with the needle of FIG. 61 deployed in tissue and readyfor retrieval;

FIG. 73 is a sectional view of the upper jaw of FIG. 64 assembled to thelower jaw and with the needle of FIG. 61 captured in the upper jaw;

FIG. 74 is a sectional view of the upper jaw of FIG. 64 assembled to thelower jaw and with the needle of FIG. 61 captured in the upper jaw andwithdrawn from the tissue;

FIG. 75 is a sectional view of the upper jaw of FIG. 64 assembled to thelower jaw and with the needle of FIG. 61 captured by the instrument andpositioned for withdrawal through a cannula;

FIG. 76 is an alternate needle having a radial shape and made ofNitinol;

FIG. 77 is a plan view of the needle of FIG. 76 prior to forming;

FIG. 78 is an end view of the needle of FIG. 76;

FIG. 79 is a plan view of an alternate needle according to theinvention;

FIG. 80 is a side view of the needle of FIG. 79;

FIG. 81 is an end view of the needle of FIG. 79;

FIG. 82 is a plan view of an alternate top jaw according to theinvention;

FIG. 83 is a side view of the alternate top jaw of FIG. 82;

FIG. 84 is a side sectional view of the alternate top jaw of FIG. 82;

FIG. 85 is an end view of the alternate top jaw of FIG. 82;

FIG. 86 is an expanded lateral sectional view of the alternate top jawof FIG. 82;

FIG. 87 is a drawing of a jawless suture punch according to the presentinvention;

FIG. 88 is a drawing of a trocar pusher adapted for use with the jawlesspunch of FIG. 87;

FIG. 89 is a drawing of the distal tip of an angled jaw or jaw-lessdesign according to the present invention;

FIG. 90 is a drawing of a particularized capsular plication suture punchfor the shoulder according to the present invention;

FIG. 91 is a simplified drawing which shows the way in which threerigidly positioned points may be used to curve a needle into a selectedradius according to the present invention;

FIG. 92 is a drawing depicted in partial transparent form, illustratinga more sophisticated jawless punch according to the present invention;

FIG. 93 is an oblique view of the device of FIG. 92;

FIG. 94 is a close-up view of the distal end including the curved tip;

FIG. 95 is a side-view of the device of FIG. 93 with the needle loadedin position;

FIG. 96 is a perspective-view of the configuration shown in FIG. 95;

FIG. 97 is a side-view showing the trocar being advanced by pushing onthe proximal end of the pusher rods;

FIG. 98 shows the needle being pushed passed the breached loadingposition, with the suture material extending out from a slot;

FIG. 99 shows the needle being deformed and pushed out the distal end;

FIG. 100 shows the needle fully advanced, now free of the distal tip ofthe instrument;

FIG. 101 is a close-up, detail view of the needle emerging from thecurved distal tip of the instrument;

FIG. 102A shows the jaws open ready to grab the tip of the needle;

FIG. 102B shows the needle grasped;

FIG. 102C shows how, even once grasped, the tip of the needle may rotatewithin the jaws;

FIGS. 103A-103C are side views of the embodiments of FIGS. 102A-102C;

FIG. 104 is a perspective view of the grasping mechanism in conjunctionwith the tip of the needle;

FIG. 105A is a first view of a needle according to the inventionparticularly suited to certain shoulder procedures;

FIG. 105B is a different view of the needle of FIG. 105A;

FIG. 105C is a end-on view of the needle of the FIGS. 105A and 105B;

FIG. 106 is a retrieval instrument associated with the needle of FIG.105;

FIG. 107A is a close-up view drawing of the retrieval tip of theinstrument of FIG. 106;

FIG. 107B is a different view of the retrieval tip;

FIG. 107C is an end-on view of the retrieval tip;

FIG. 108 shows a distal portion of an insertion instrument; and

FIG. 109A through 109K show the way in which the needle of FIG. 105,insertion of FIG. 108 and retrieval instrument of FIGS. 106 and 109 areused.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is more particularly described in the followingexamples that are intended to be illustrative only since numerousmodifications and variations therein will be apparent to those skilledin the art. As used in the specification and in the claims, the singularform “a,” “an,” and “the” may include plural referents unless thecontext clearly dictates otherwise. Also, as used in the specificationand in the claims, the term “comprising” may include the embodiments“consisting of and ” consisting essentially of.”

The present invention will now be further described through thefollowing drawings. It is to be understood that these drawings arenon-limiting and are presented to provide a better understanding ofvarious embodiments of the present invention and are not intended torepresent every possible embodiment of the present invention.

Referring to the drawings, as best seen in FIGS. 1 through 9, theinstrument body 11 has a proximal end 1 and a distal end 2. The distalend further includes a fixed portion (or fixed jaw) 3 and a movableportion (or moveable jaw) 4. The movable portion 4 is rotatable aboutpin 5 passing through the movable portion 4 and fixed portion 3 therebyforming a hinge.

The position of movable jaw 4 is determined by positioning rod 6 whichtransmits an opening or closing force to movable portion 4 via hinge pin7. The position of positioning rod 6 is determined by the position ofmovable handle 8, which is connected to the proximal end of positioningrod 6 through pin 9. The positioning rod 6 passes through elongatedsection 18 of instrument body 11 and through passage 17.

Movable handle 8 is rotatably affixed to the instrument body 11 by pin10 so that rotating movable handle 8 counterclockwise opens movable jaw4 and rotating movable handle 8 clockwise closes movable jaw 4 with aclosure force proportional to that applied between movable handle 8 andfixed handle 12. Closure pressure between the jaws may be maintained bya ratcheting action created through the interraction between toothsection 13 of movable handle 8 and serrations 14 on arcuate section 15of fixed handle 12.

Closure pressure may be released by elastically deforming arcuatesection 15 upward with pressure applied to proximal end 16 of thearcuate section. Fixed jaw 3 and movable jaw 4 may include serrations 8formed on their angularly transposed surfaces to facilitate the graspingof tissue placed between them. Removable trocar 70 protrudes from theproximal end of instrument body 11.

As is best seen in FIGS. 11 through 13, one embodiment of the needle 20has a proximal end 21 and a distal end 22, and a rectangularcross-section 27 with upper surface 28, lower surface 29 and lateralsurfaces 30. The proximal end 21 includes a contoured proximal surface23, conical in shape in one embodiment, and having a conical angle 24and a conical axis 25 coaxial with needle centerline 26. The distal end22 is shaped to form a cutting edge 28 having included angle 27. Suture31 is connected to a needle lateral surface 30 at a distance 32 from theneedle proximal end.

As is best seen in FIGS. 4, 5, 9, and 10, the instrument body 11 has acontinuous passage 40 of varying cross-section extending from theproximal-most face 41 of instrument body 11 to the upper surface 42 offixed jaw 3 near the jaw's distal tip. In section 43, extending adistance 44 from proximal face 41, the passage has a cylindricalcross-section of a specified diameter 56 as shown in FIGS. 7 and 8. Insection 45, extending a distance 46 from the distal end of section 43,the passage is a rectangular channel 44, the height of the channel 51being slightly greater than the thickness 45 of needle 20. Distance 46is sufficiently longer than the length of needle 20 to allow easyplacement of the needle in the slot.

Section 47 of the slot extends from the distal end of section 45 to thetermination of the slot at the top surface 42 of fixed jaw 3 andbeneficially includes of a linear portion 48 and a radial portion 49having a known radius 50. As is best seen in FIG. 5, the cross-sectionof channel 40 in section 47 is rectangular having a height 51 slightlygreater than the thickness 45 of needle 20 and a width 52 slightlygreater than width 53 of needle 20. A slot 54 having a height 55 lessthan height 51 of passage 40 extends through the entirety of section 47.

As is best seen in FIGS. 14 through 17, upper jaw 4 contains a shapedpassageway 60 having a width 61 slightly larger than width 52 of passage40 and extending from the jaw's lower surface 63 to upper surface 64. Asbest seen in FIGS. 4 and 10, upper jaw 4 protrudes distally a distance62 beyond lower jaw 3.

Referring to FIGS. 18 through 22, the force-supplying mechanism is atrocar 70 that is an assembly including a stepped cylindrical rod 71 andhub 72 and having a distal end 73 and proximal end 74, with the hubbeing attached to proximal end 74. Stepped metallic cylindrical rod 71features a larger diameter section 75 of specified length 76 anddiameter 77, with the diameter being slightly smaller than diameter 56of section 43 of passage 40 so allowing trocar 70 may move freely withininstrument body 11 when inserted into passage 40. Cylindrical rod 71 hasa smaller diameter section 78 of specified length 79 and diameter 80,with the diameter being slightly smaller than height 51 of sections 45and 47 of passage 40 allowing trocar 70 to move freely within elongatedsection 18 of instrument body 11 when inserted into passage 40. Rod 71is hardened throughout its length to prevent bending, except section 81extending a length 82 from distal tip 73 is annealed for highmalleability. Distal tip 73 is formed to a conical shape of conicalangle 83, with the conical angle being equal to conical angle 24 onproximal end 21 of needle 20.

Referring to FIGS. 23 and 24, when prepared for use, needle 20 isinserted laterally into section 45 of passage 40 with the lateralsurface 30 with suture 31 facing the open side of channel 40 and suture31 extending from elongated section 18 of body 11. After insertion,needle 20 is moved distally to section 47 of channel 40; trocar 70 isinserted into channel 40 of instrument body 1, and positioned as shownin FIGS. 23 and 24.

Referring to FIGS. 25 and 26, when using the instrument to pass a suturethe movable jaw 4 is opened using movable handle 8. Trocar 70 isinserted into instrument body 11 until trocar distal end 73 engagesneedle proximal end 21. Suture 31 carried by the needle 20 moves freelyin slot 54.

During use of the device, as seen best in FIGS. 27 and 28, tissue isgrasped between upper jaw 4 and lower jaw 3. Referring to FIGS. 29 and30, advancing trocar 70 a distance 85 distally causes needle 20 to movedistally in channel 20, the distal portion of the needle being formed toa radius 50 by the radial portion 49 of passage 40.

Referring to FIGS. 31 and 32, advancing the trocar an additionaldistance 86 causes needle 20 to be formed to a radial shape of radius87, radius 87 being larger than radius 50 of section 49 of passage 40due to spring back of the needle after leaving the passage radialsection 49. Needle 20 follows a radial path through the tissue.Advancing trocar 70 an additional distance 88 (see FIGS. 33 and 34)causes needle 20 to advance along its radial path until needle distaltip protrudes above top surface 64 of movable jaw 4, having passedthrough jaw 4 via passage 60.

As is best seen in FIGS. 35 and 36, advancing trocar 70 distally untilhub 72 contacts distal face 41 of instrument body 11 advances needle 20further through the tissue, with distal tip 73 of trocar 70 assuming aradial shape of radius 87 as it passes through radial portion 49 ofpassage 40. Alignment between trocar distal tip 73 and needle proximalend 21 is maintained by engagement of the needle proximal end conicalrecess with the with the trocar distal tip conical protrusion, needleproximal end conical radius 24 and trocar distal tip conical radius 83being equal. In this manner, needle 20 and suture 31 are advanced adistance 89 into the tissue beyond the top surface of lower jaw 3.

As is best seen in FIGS. 37 and 38, withdrawing trocar 70 a distance 90causes the trocar distal tip 73 to be withdrawn from the tissue into thedistal portion of passage 40, leaving needle 20 and suture 31 in thetissue, with needle distal tip 22 protruding well above the top surfaceof upper jaw 3. As seen in FIGS. 39 and 40, upper jaw 3 is now retractedwith needle 20 moving freely within passage 60. Referring now to FIGS.41 and 42, withdrawing the instrument axially causes needle 20 in slot60 of upper jaw 3 to be pulled free from the tissue with suture 31 nowpassing through the tissue. Referring to FIGS. 43 and 44, closing jaw 3causes it to grasp needle 20 thereby allowing further retraction of theneedle and the suture. As seen in FIGS. 45 and 46, jaws 3 and 4 may beopened thereby freeing needle 20, and the needle rotated 90 degrees andre-grasped by jaws 3 and 4.

Although the above description references “needle 20,” various otherneedle designs are equally applicable to the invention. In anotherembodiment, shown in FIGS. 47 through 49, needle 92 has a cross-sectionwith two parallel sides, the lateral faces having a nearly radialprofile, a shape producible by coining a cylindrical needle.Additionally, prior to delivery of the suture material, the suturematerial may be a standard suture or may be a smaller suture. As shownin FIG. 47 a, the suture material may be looped back into the needle 92such that when the needle 92 is delivered to the tissue, a loop ofsuture material is delivered that may then be used for other purposes,such as an eyelet for the transfer of other sutures.

In another embodiment, shown in FIGS. 50 through 52, needle 94 has anon-uniform cross-section, upper and lower surfaces 95 and 96 having aplurality of angled surface segments 98 of angle 95 each surfaceterminating in a radius 96 so as to form a series of notches useful inengaging comers of passage 60 in upper jaw 3 so as to aid in needleretraction during axial withdrawal of the instrument.

In addition to alternative needle designs, jaw construction is likewisevariable in accordance with the invention. In another embodiment, bestseen in FIGS. 53 through 56, upper jaw 100 is of similar construction toupper jaw 3 except that passage 60 has been replaced with slot 101. Asis best seen in FIGS. 57 through 59, the distal protrusion 62 of upperjaw 4 beyond lower jaw 3 is required to allow needle 20 to enter passage60 throughout the range of positions of upper jaw 4. FIG. 60 is asectional view of upper and lower jaws with jaws opened 100 percent andthe suture being pulled through the tissue.

A further alternate needle 201 is shown in FIGS. 61 through 63. As isbest seen in FIG. 62, the needle of thickness 220 has a distal end 202and a proximal end 203, with the distal end formed to a wedge shapehaving included angle 204 so as to form a cutting edge 205. The proximalend 203 has a conical shape 206 formed therein and having an angle 207equal to angle 83 on the distal tip of trocar 70 shown in FIGS. 18through 22. As is best seen in plan view FIG. 61, needle 201 has threesections distinguished by their width. Proximal section 208 and distalsection 209 have a width 210, while medial section 211 has a width of212 than width 211. Distal section 209 is not of constant width, butrather tapers to a width 213 at its distal tip. The transition frommiddle section 211 to proximal section 208 is a taper of length 214 andangle 215. Suture 216 is connected to lateral surface 217 of proximalsection 208 a distance 218 from proximal end 203.

An alternate upper jaw to be used in conjunction with alternate needle201 is shown in FIGS. 64 through 71. As is best seen in FIGS. 64, 66 and68, upper jaw 110 is constructed like upper jaw 4 having a distal end111 and a proximal end 112, except that upper jaw 110 has a distal endslot 113, the distal slot having a proximal portion 114 and a distalportion 120, and the portions being distinguished by their width.Proximal portion 114 has a length 125 and a width 115 which is slightlylarger than width 210 of proximal section 208 and distal section 209 ofneedle 201 as shown in FIG. 61. Distal portion 120 has a width of 121which is slightly larger than width 212 of middle section 211 of needle201 shown in FIG. 61.

As is best seen when viewing jaw 110 laterally as in FIG. 65, distalportion 111 of jaw 110 has a hooked portion 126 formed therein, thehooked portion having a radius 127 and a height 128, height 128 beingsomewhat larger than thickness 220 of needle 201 as seen in FIG. 62. Asis best seen in axial sectional view FIG. 71, proximal portion 114 ofslot 113 has a portion 130 of height 131 with parallel sides and aportion 132 of height 133 whose lateral facing sides are angled outwardat angle 134 so that the bottom of the slot is wider than the top of theslot.

The functioning of alternate needle 201 and alternate jaw 110 is bestseen in FIG. 72 through 75. Functioning of the needle and jaw are asexplained previously except, referring to FIG. 72, needle 201 being of ashorter length than that of needle 20 and trocar 170 being of a shorterlength than trocar 70, when trocar 70 is fully inserted to the limit ofits travel, the portion of needle 201 remaining within tissue 171 isgreater than that remaining in the previously explained embodiments. Thelength 175 of the portion of needle 201 protruding beyond tissue 171 issufficient to cause the distal end of medial portion 211 of needle 201to extend above surface 172, needle 201 having passed through proximalportion 114 of slot 113, and, as shown in FIG. 72 passed into distalportion 120 of slot 113 due to movement of the instrument proximally.

In this embodiment, needle 201 is prevented from disengagement from thedistal portion 120 of slot 113 because the width 210 of needle distalportion 209 is greater than width 121 of slot distal portion 120. Needle201 is able to move freely within slot 113 parallel to the axis of theslot as width 212 of needle medial portion 211 is less than width 121 ofdistal portion 209 of slot 113. Referring to FIG. 73, withdrawing theinstrument proximally causes needle 201 to move distally and pivotwithin distal portion 120 of slot 113 so as to engage with the hooksegment 126 of jaw 110, thereby allowing needle 201 to be extracted fromtissue 171, causing suture 216 to be pulled through the tissue. As isbest seen in FIG. 74, after needle 201 is free of tissue 171 upper jaw110 may be closed and additional suture pulled through the tissue. Asseen in FIG. 75, jaw 110 may be closed totally thereby allowing needle201 and suture 216 to be withdrawn through a cannula.

An alternate needle made of Nitinol and formed to a radial shape duringmanufacture is shown in FIGS. 76 through 78. Manufacture of needle 400is accomplished in two steps, namely the cutting of the needle blankprofile 401 from sheet material, and forming of the needle to a shapehaving radius 402, with radius 402 being equal to forming radius 50 oflower jaw 3 as shown in FIG. 10. Needle 400 may be used in the samemanner as previous embodiments as it will be constrained in astraightened state by channel 47 (FIG. 9) prior to deployment. Needlecapture and retrieval are accomplished in the same manner as needle 201described previously and shown in FIGS. 72 through 75. Conversely, aNitinol needle may be used having a linear shape, which is constrainedinto the radial shape as the needle passes through the radius of thelower jaw 3. Additionally, in other embodiments, a smaller Nitinolneedle, i.e. having a smaller diameter, may be used for creating alooped suture in the tissue wherein the smaller needle creates a loop inthe suture material as it is delivered due to the reduced diameter ofthe needle.

An alternate needle 500 having multiple “barbs” displaced along itslateral surfaces is shown in FIGS. 79 through 81. The needle features adistal end 501 shaped to a cutting edge 506 having included angle 507,and a proximal end 502 having a convex conical shape 503 with conicalangle 504. The conical angle is, in one embodiment, equal to distal tipangle 83 of trocar 70, shown in FIG. 21. Suture 508 is attached to alateral face 510 a distance 511 from distal end 502. Needle 500 has awidth 507 and a number of pyramid-shaped “barbs” 512 displaced alonglateral surfaces 510, the lateral distance 513 between barb tips beinggreater than width 507. The barb protrusions are pyramidal in shapehaving a length 514, width 515 and height 516, the distal edge 517forming an angle 518 with the lateral surface 510.

FIGS. 82 through 86 show an alternate upper jaw for use with needle 500.Jaw 600 in constructed in the manner of jaw 4, except that jaw 600includes a hollow structure of wall thickness 602 forming a capturespace 601. The capture space 601 is defined by the walls of the jaw andby the inner surface 603 of the jaw lower wall 604. Jaw lower wall 604has a slot 605 of width 606, width 606 being greater than width 507 ofneedle 500, but less than distance 513 between barb tips of needle 500.The lower section of slot 605 is tapered outward so as to aid needle 500in entering slot 605.

Needle 500 and upper jaw 600 are used in the same manner as needle andjaw configurations previously disclosed; that is, needle 500 is formedto a radial shape by the instrument, passes through tissue confined bypressure from the upper and lower jaws, and enters the upper jaw whereit is captured for retrieval. Needle 500 and jaw 600 vary in the methodof capture. Distal tip 501 of needle 500 enters slot 605 of jaw 600, andvia the slot enters space 601. Slot 605, being less in width thandistance 513 between the needle barb tips, causes the barb tips todeform as they pass into space 601 via slot 605. Also, because wallthickness 602 is rather thin, jaw 600 will spread slightly so as toallow the barbs to pass. Because the barb proximal surfaces are squarerather than tapered, the needle is retained in the slot.

The embodiments described thus far included a pair of jaws, beneficiallya fixed jaw and movable jaw, with the later being additionallyresponsible for any capture of a needle having been radially deformedand passed through tissue. Although the invention has been described interms of a fixed jaw and a movable jaw, it will be apparent to those ofskill in the art of mechanical design that versions of the inventionwherein both jaws move are also anticipated, assuming appropriateinteraction associated with needle curvature and any capture of theneedle.

In addition, there are situations, and embodiments of this invention,where capture is performed not by a jaw coupled to the same instrument,but rather, through the use of an additional instrument. Reference toFIGS. 87-91, which illustrate a simpler suture punch according to theinvention, which is similar to the embodiments described above, but doesnot include an upper jaw to hold tissue and/or retain a needle onceformed. Nevertheless, the same type of malleable needle according to theinvention having a suture/suture loop is inserted into these simplerdevices, and pushed down the channel by a pusher, which acts as theforce-supplying mechanism. Since the terminal action of the needle isthe same as that used with the more sophisticated device as describedherein, the shaft of the channel must be stiff enough to resist aperpendicular vector force required to push the needle through thetissue. One advantage of these alternative designs is that suchinstruments may be used to plicate the shoulder capsule from the insidearthroscopically. FIG. 87 is a drawing of a jawless suture punchaccording to the invention, including a curved distal end 802, and aproximal end 804 including an insertion point 806. FIG. 88 is a drawingof a pusher adapted for use with the jawless punch of FIG. 87. Thepusher includes a sharpened malleable/spring steel tip 812 coupled to ablunt 814 through an eyelet 816 to receive a thread or suture loop. Inoperation, the curved tip 802 is placed next to tissue to be sutured,and the sharp tip inserted into the insertion point 806. The sharp tipis then advanced with the pusher of FIG. 88 through the tissue, allowingthe suture to be pulled through the tissue as well.

FIG. 89 is a drawing of a lower jaw of a suture punch or a jaw-lessdesign according to the invention. According to this embodiment, amalleable needle is inserted into a loading slot 820 such that the tipof the needle is proximate to the distal end by a distance of ⅛ inch, orthereabouts. The instrument is inserted through cannula, upon which timethe tissue is grasped and a flexible trocar is pushed down trocarchannel 822. As the flexible tip of the trocar nears the needle slot820, the bend in the channel directs the tip down the needle slot,engaging the proximal end of the needle. As the trocar is advancedfurther, the needle is pushed through the forming section of the lowerjaw, resulting in a deformation similar if not identical to the otherembodiments described herein. FIG. 90 is a drawing of a particularizedcapsular plication suture punch for the shoulder according to theinvention. Distance d indicates the portion of the capsule to beplicated, with the capsule surface being shown at 902. A malleableneedle is inserted into the proximal end of the device, which penetratesinto and out of the capsule, with the entire instrument remaining on oneside of the surface 902. The depth of the penetration may be controlledfor the curvature of the insertion channel, and the malleabilitycharacteristics of the needle. FIG. 91 is a simplified drawing whichshows the way in which three rigidly positioned points may be used tocurve a needle into a selected radius according to the invention. Oncethe needle and suture passes through the capsule, a separate needlecapture mechanism 910 may be used to pull the suture through, asdescribed elsewhere herein.

FIG. 92 is a drawing depicted in partial transparent form, illustratinga more sophisticated jawless punch according to one embodiment of theinvention, including yet a further alternative needle including a distaltip configured for grasping with a separate instrument. The instrumentdepicted generally at 920 includes a body portion having a squeezehandle 922 coupled to a ratchet 924 which engages with barbs 926 on apusher mechanism. The pusher mechanism extends through the barrel of theinstrument down to the distal tip 930, which terminates in a curvedportion 932, and includes a breach loading slot 934 to receive a needle940 attached to suture 941 and including a distal tip 942 configured forgrasping. FIG. 93 is an oblique drawing of the device of FIG. 92. FIG.94 is a close-up view drawing of the distal end 930 including curved tip932, breach loading slot 934 and specialized needle 940 having a tip 942configured for manual grasping, the needle 940 being attached at itsproximal end to suture material 941. FIG. 95 is a side-view drawing ofthe device of FIG. 93 with the needle loaded in position; FIG. 96 is aperspective-view drawing of the configuration shown in FIG. 95. FIG. 97is a side-view drawing showing the trocar being advanced by pushing onthe proximal end of the pusher rods. FIG. 98 is a detail drawing showingthe needle being pushed passed the breached loading position, with thesuture material extending out from a slot, and with the needle inposition just prior to deformation. FIG. 99 is a drawing which shows theneedle being deformed and pushed out the distal end, as handle 922 iscompressed, causing the ratchet 924 to advance the barbs 926 on thepusher rod. FIG. 100 is a drawing which shows the needle fully advanced,now free of the distal tip of the instrument. FIG. 101 is a close-up,detail view of the needle emerging from the curved distal tip of theinstrument.

As discussed above, with respect to the jawless embodiments of thisinvention, a separate instrument would generally be used to grasp theformed needle, having passed through tissue to be sutured. Whileconventionally available tools such as forceps, and the like, may beused for such purpose, particularly with respect to the specializedneedle shown in FIG. 94 and elsewhere herein, specialized needlegrasping instruments may be provided, as shown in FIGS. 102-104. FIG.103A is a drawing which shows a grasping mechanism 1002 having aspecially shaped set of jaws to capture the tip of certain needlesdescribed herein. In particular, the embodiments of FIGS. 102-104 arespecially suited to grasp the tip of the needle best seen in FIG. 94.FIG. 102A shows the jaws open ready to grab the tip of the needle. FIG.102B shows the needle grasped, and FIG. 102C shows how, even oncegrasped, the tip of the needle may rotate within the jaws. FIGS.103A-103C are side views of the embodiments of FIG. 102A-102C, and FIG.104 is a perspective view of the grasping mechanism in conjunction withthe tip of the needle.

Yet a further embodiment, intended for applications such as the repairof torn meniscus, torn labrum, capsular reefing to the labrum and otherapplications, is described in the following text and FIGS. 105 through109. This embodiment is different from the previous embodiments in thatthe distal end of the insertion instrument is configured so that theneedle exits the instrument in a direction that is axial to theinstrument, wherein a normal to the distal-most surface is parallel tothe axis of the instrument. The needle is formed to a somewhat largerradius so that when it is fully inserted the needle tip protrudes fromthe upper (or lower) surface of the tissue undergoing repair, the needlebeing formed, in one embodiment, less than 90 degrees. When the needleis fully inserted, the insertion instrument is removed leaving theneedle and suture embedded in the tissue with its distal tip exposed.

The retrieval instrument distal end is somewhat like the upper jaw ofcertain previous embodiments in that it has a hook shape designed toallow the captured needle to pivot freely in the plane in which it isformed. A feature allows the tool to exert a force on a needle tip inthe distal as well as the proximal direction. The retrieval instrumentdistal end is also slotted, the slot having a width slightly greaterthan that of the reduced width region of the needle, but less than thewidth of the needle distal tip.

In use, the wedge shaped distal end of the instrument is inserted sothat the reduced region of the needle is engaged by the slot in theinstrument. Moving the instrument distally causes the needle to bepulled further through the tissue. When the head is fully engaged in theslot the needle is pulled the rest of the way through the tissue bymoving the instrument distally a distance sufficient to free the needlefrom the tissue and expose a short length of suture. The retrievalinstrument is then moved proximally with the needle pivoting in thedistal hook so that it may be withdrawn through the cannula. After theneedle is freed from the tissue, the retrieval instrument may be rotatedabout its axis so that the needle pivots in a plane in which there issufficient space for this to occur.

Referring to the drawings, as best seen in FIGS. 105A through 105C,needle 2001 of width W₁ (2004) and height H₂ (2005) has a distal end2002 and a proximal end 2003. A middle region 2009 having a width W₂(2006) forms “shoulders” 2012 at its distal end 2002 which is sharpened.A suture 2007 is attached to lateral surface 2008 a distance L₁ (2010)from distal-most surface 2011.

Referring to FIG. 106, retrieval instrument 2020 has a proximal portion2021 formed to a handle shape and an elongated distal portion 2022terminating in distal tip 2023. Referring to FIGS. 107A through 107C,distal tip 2023 has a slot 2024 of width W₃ (2025) which is slightlylarger than width W₂ (2006 in FIG. 105A) but less than W₁ (2004). Theprofile of distal end 2023 has a distal surface 2026 inclined at anangle A₁ (2027) and a capture region 2028 bounded on its distal end byhook-shaped surface 2029 and on its proximal end by lateral surface 2030displaced from surface 2029 a distance L₂ (2031) and surface 2032.

FIG. 108 shows the distal portion 2040 of an insertion instrument ofthis embodiment. Needle 2001 is positioned in the forming channel 2047and suture 2007 is affixed to the needle. Distal portion 2040 has tworadii, R₁ (2041) and R₂ (2042) which together displace forming channel2045 a distance D₁ (2046). Radius R₂ (2042) forms the needle to a radialshape having a radius R₃ (2049 in FIG. 109C) slightly larger than R₂(2042). A normal to distal-most surface 2048 is coaxial with the axis ofthe axis of portion 2040.

Referring to FIG. 109A, tissue 43 is to be sutured to tissue 2044. InFIG. 109B, the “tear” is closed by applying force to tissue 2043 usingdistal portion 2040. In FIG. 109C, needle 2001 has been inserted in thesame manner as in the previous embodiment. In FIG. 109D, the insertioninstrument has been removed and needle 2001 remains in place with suture2007. In FIG. 109E, retrieval instrument 2020 has been brought intoposition. FIG. 109F, distal tip 2023 has been inserted such that needle2001 is engaged in slot 2024 and surface 2026 (see FIG. 107B) acting onshoulders 2012 (FIG. 105A) of needle 2001 has displaced the needledistally in tissue 2043 and 2044.

Referring to FIG. 109G, distal end 2002 of needle 2001 is captured inregion 20028 (FIG. 107B). Displacing retrieval instrument 2020 distally(FIG. 109H) causes needle 2001 to be extracted from tissue 2043 therebypulling suture 2007 through the tissue. In FIG. 109I additional suturehas been pulled through the tissue. In FIG. 109J, retrieval instrument2020 has been moved proximally causing needle 2001 to pivot in distaltip 2023 . In FIG. 109K, needle 2001 has pivoted into position forretrieval through a cannula.

Although the illustrative embodiments of the present disclosure havebeen described herein with reference to the accompanying drawings andexamples, it is to be understood that the disclosure is not limited tothose precise embodiments, and various other changes and modificationsmay be affected therein by one skilled in the art without departing fromthe scope of spirit of the disclosure. All such changes andmodifications are intended to be included within the scope of thedisclosure as defined by the appended claims.

1. A method for suturing, comprising: placing a suture-passing deviceproximate to a surface of a tissue portion through which suture is to bepassed; and actuating the suture-passing device thereby causing a needleto be bent within the suture-passing device and to be passed into thesurface, the needle remaining in a bent condition in the tissue; whereinthe needle comprises at least one suture material coupled to the needle.2. The method of claim 1, further comprising removing the needle fromthe material by pulling the needle in a direction of a distal tip of theneedle.
 3. The method of claim 2, wherein removing the needle from thematerial comprises removing the needle by capturing the needle with aneedle capture mechanism.
 4. The method of claim 3, wherein removing theneedle from the material comprises removing the needle by capturing theneedle with a needle capture mechanism, wherein the needle capturemechanism is selected from the group consisting of an aperture, a slot,and a cavity.
 5. The method of claim 3, wherein removing the needle fromthe material comprises removing the needle by capturing the needle witha needle capture mechanism, wherein the needle capture mechanism iscoupled to a distal end of the suture-passing device.
 6. The method ofclaim 5, wherein removing the needle from the material comprisesremoving the needle by capturing the needle with a needle capturemechanism, wherein the needle capture mechanism comprises a jawpivotally coupled to a distal end of the suture-passing device.
 7. Themethod of claim 1, wherein placing a suture-passing device proximate toa surface of a tissue portion through which suture is to be passed,comprises placing a suture-passing device comprising a shaft slidablypositioned in a shaft chamber and a needle positioned in a needlepassage that is configured to receive a needle and to allow the shaft tobe slidably inserted to move the needle, wherein the needle passageincludes a nonlinear portion having a first radius that is adapted tobend the needle as the needle is moved through the nonlinear portion ofthe needle passage.
 8. The method of claim 7, wherein placing asuture-passing device proximate to a surface of a tissue portion intowhich the suture is to be inserted comprises placing a suture-passingdevice, wherein the needle passage includes a slot enabling the needleto be inserted into the needle passage.
 9. The method of claim 8,wherein placing a suture-passing device proximate to a surface of atissue portion into which the suture is to be inserted comprises placinga suture-passing device, wherein the slot comprises an elongated slot atdistal end of the suture-passing device, wherein the slot includes anarrowed portion positioned adjacent to the nonlinear portion of theneedle passage, which enables suture material extending from the needleto extend from the slot as the needle is pushed through the nonlinearportion.
 10. The method of claim 7, wherein placing a suture-passingdevice proximate to a surface of a tissue portion into which the sutureis to be inserted comprises placing a suture-passing device, wherein thenonlinear portion of the needle passage is a continuous curve.
 11. Themethod of claim 1, wherein placing a suture-passing device proximate toa surface of a tissue portion into which the suture is to be insertedcomprises placing a suture-passing device, having a needle passage thatincludes at least one flat side to prevent rotation of the needle as theneedle passes through a nonlinear section.
 12. The method of claim 1,wherein placing a suture-passing device proximate to a surface of atissue portion into which the suture is to be inserted comprises placinga suture-passing device, wherein the needle includes at least oneindented portion to assist with deformation as the needle passes througha nonlinear portion.
 13. The method of claim 1, wherein placing asuture-passing device proximate to a surface of a tissue portion intowhich the suture is to be inserted comprises placing a suture-passingdevice, wherein the needle includes at least one barb protruding from aside surface of the needle proximate to a tip of the needle.
 14. Themethod of claim 1, wherein actuating the suture-passing device comprisesactuating a handle coupled to a ratchet such that when the handle isactuated, the needle is pushed by a distal end of a shaft through anonlinear portion of a needle passage, thereby causing the needle to beinelastically deformed from a first shape to a second shape.
 15. Themethod of claim 1, wherein placing a suture-passing device proximate toa surface of a tissue portion into which the suture is to be insertedcomprises placing a suture-passing device comprising a shaft chamberdefining a primary axis and the nonlinear portion being positionedoff-axis.
 16. A method for passing a suture through tissue, comprising:placing a substantially straight malleable needle with side loadedsuture into a suture-passing device; placing the suture-passing deviceinto close proximity with a target tissue; actuating the suture-passingdevice thereby causing the needle to be inelastically deformed within aneedle passage of the suture-passing device from a first shape to asecond shape; passing the needle through the target tissue so that theneedle may be captured on the far side of the target tissue by a needlecapture mechanism; and pulling the needle through the target tissue. 17.The method of claim 16, wherein pulling the needle through the targettissue comprises pulling the needle by capturing the needle with aneedle capture mechanism.
 18. The method of claim 16, wherein pullingthe needle through the target tissue comprises pulling the needle bycapturing the needle with a needle capture mechanism, wherein the needlecapture mechanism is selected from the group consisting of an aperture,a slot, and a cavity.
 19. The method of claim 16, wherein pulling theneedle through the target tissue comprises pulling the needle bycapturing the needle with a needle capture mechanism, wherein the needlecapture mechanism is coupled to a distal end of the suture-passingdevice.
 20. The method of claim 19, wherein pulling the needle throughthe target tissue comprises pulling the needle by capturing the needlewith a needle capture mechanism, wherein the needle capture mechanismcomprises a jaw pivotally coupled to a distal end of the suture-passingdevice.
 21. The method of claim 16, wherein placing the suture-passingdevice into close proximity with a target tissue comprises placing asuture-passing device comprising a shaft slidably positioned in a shaftchamber and a needle positioned in the needle passage that is configuredto receive a needle and to allow the shaft to be slidably inserted tomove the needle, wherein the needle passage includes a nonlinear portionhaving a first radius that is adapted to bend the needle as the needleis moved through the nonlinear portion of the needle passage.
 22. Themethod of claim 21, wherein placing the suture-passing device into closeproximity with a target tissue comprises placing a suture-passingdevice, wherein the needle passage includes a slot enabling the needleto be inserted into the needle passage.
 23. The method of claim 22,wherein placing the suture-passing device into close proximity with atarget tissue comprises placing a suture-passing device, wherein theslot comprises an elongated slot at distal end of the suture-passingdevice, wherein the slot includes a narrowed portion positioned adjacentto the nonlinear portion of the needle passage which enables suturematerial extending from the needle to extend from the slot as the needleis pushed through the nonlinear portion.
 24. The method of claim 21,wherein placing the suture-passing device into close proximity with atarget tissue comprises placing a suture-passing device, wherein thenonlinear portion of the needle passage is a continuous curve.
 25. Themethod of claim 16, wherein placing the suture-passing device into closeproximity with a target tissue comprises placing a suture-passing devicehaving the needle passage that includes at least one flat side toprevent rotation of the needle as the needle passes through a nonlinearsection.
 26. The method of claim 16, wherein placing the suture-passingdevice into close proximity with a target tissue comprises placing asuture-passing device, wherein the needle includes at least one indentedportion to assist with deformation as the needle passes through anonlinear portion.
 27. The method of claim 16, wherein placing thesuture-passing device into close proximity with a target tissuecomprises placing a suture-passing device, wherein the needle includesat least one barb protruding from a side surface of the needle proximateto a tip of the needle.
 28. The method of claim 16, wherein actuatingthe suture-passing device comprises actuating a handle coupled to aratchet such that when the handle is actuated, the needle is pushed by adistal end of a shaft through a nonlinear portion of the needle passage,thereby causing the needle to be inelastically deformed from a firstshape to a second shape.
 29. The method of claim 16, wherein placing thesuture-passing device into close proximity with a target tissuecomprises placing a suture-passing device comprising a shaft chamberdefining a primary axis and the nonlinear portion being positionedoff-axis.
 30. A method of inelastically deforming a needle from a firstshape to a second shape within a body for the purpose of passing asuture through tissue, comprising: placing a needle having a firstsubstantially straight shape into a suture-passing device; and actuatingthe suture-passing device causing the needle to be inelasticallydeformed to a second shape such that the needle remains in the secondshape after ejected from the suture-passing device.
 31. The method ofclaim 30, wherein placing a needle having a first substantially straightshape into a suture-passing device comprises using said suture-passingdevice comprising an elongated tube having a distal end terminating in anonlinear portion; and a trocar positioned within the elongated tube,the trocar including a distal end operative to push the needle throughthe nonlinear portion.
 32. The method of claim 30, further comprisingpulling the needle through the tissue by capturing the needle with aneedle capture mechanism.
 33. The method of claim 32, wherein pullingthe needle through the tissue comprises pulling the needle by capturingthe needle with a needle capture mechanism, wherein the needle capturemechanism is selected from the group consisting of an aperture, a slot,and a cavity.
 34. The method of claim 32, wherein pulling the needlethrough the tissue comprises pulling the needle by capturing the needlewith a needle capture mechanism, wherein the needle capture mechanism iscoupled to a distal end of the suture-passing device.
 35. The method ofclaim 34, wherein pulling the needle through the tissue comprisespulling the needle by capturing the needle with a needle capturemechanism, wherein the needle capture mechanism comprises a jawpivotally coupled to a distal end of the suture-passing device.
 36. Themethod of claim 30, wherein actuating the suture-passing devicecomprises actuating a suture-passing device comprising a shaft slidablypositioned in a shaft chamber and a needle positioned in a needlepassage that is configured to receive a needle and to allow the shaft tobe slidably inserted to move the needle, wherein the needle passageincludes a nonlinear portion having a first radius that is adapted tobend the needle as the needle is moved through the nonlinear portion ofthe needle passage.
 37. The method of claim 36, wherein actuating thesuture-passing device comprises actuating a suture-passing device,wherein the needle passage includes a slot enabling the needle to beinserted into the passage.
 38. The method of claim 37, wherein actuatingthe suture-passing device comprises actuating a suture-passing device,wherein the slot comprises an elongated slot at distal end of thesuture-passing device, wherein the slot includes a narrowed portionpositioned adjacent to the nonlinear portion of the needle passage,which enables suture material extending from the needle to extend fromthe slot as the needle is pushed through the nonlinear portion.
 39. Themethod of claim 36, wherein actuating the suture-passing devicecomprises actuating a suture-passing device, wherein the nonlinearportion of the needle passage is a continuous curve.
 40. The method ofclaim 30, wherein actuating the suture-passing device comprisesactuating a suture-passing device having a needle passage that includesat least one flat side to prevent rotation of the needle as the needlepasses through a nonlinear section.
 41. The method of claim 30, whereinactuating the suture-passing device comprises actuating a suture-passingdevice, wherein the needle includes at least one indented portion toassist with deformation as the needle passes through a nonlinearportion.
 42. The method of claim 30, wherein actuating thesuture-passing device comprises actuating a suture-passing device,wherein the needle includes at least one barb protruding from a sidesurface of the needle proximate to a tip of the needle.
 43. The methodof claim 30, wherein actuating the suture-passing device comprisesactuating a handle coupled to a ratchet such that when the handle isactuated, the needle is pushed by a distal end of a shaft through anonlinear portion of a needle passage, thereby causing the needle to beinelastically deformed from a first shape to a second shape.
 44. Themethod of claim 30, wherein actuating the suture-passing devicecomprises actuating a suture-passing device comprising a shaft chamberdefining a primary axis and the nonlinear portion being positionedoff-axis.